Successful Treatment Of Paranoia Trial, 2024

Yiend, Jenny (2025). Successful Treatment Of Paranoia Trial, 2024. [Data Collection]. Colchester, Essex: UK Data Service. 10.5255/UKDA-SN-857941

Paranoia is linked to several mental health conditions, including psychosis and leads to distress and impairment in work, family and social functioning. Recent advances in thinking suggest that treatments might be more effective if they focus on one particular symptom at a time and try to treat that rather than trying to treat the whole disorder in one go. This study proposes to develop and test a mobile app version of a new therapy for paranoia called CBM-pa. CBM-pa is a self-administered psychological therapy that has been developed by combining basic research on biases in paranoia with established techniques that can change these biases. CBM-pa is computerised and involves reading text that could be interpreted in a paranoid way (such as the stare of a stranger which could reflect harmful intentions). The therapy encourages readers to make the alternative interpretation (such as the stare reflecting harmless curiosity) by using word tasks and questions. A six-session version has been developed and a feasibility study has been completed with promising results. In year 1 of this study we will develop CBM-pa into a more accessible and engaging 12- session app for mobile phones, called STOP: Successful Treatment of Paranoia, by adding 6 newly created sessions. In years 2-4 we will give patients STOP alongside their usual treatment and compare this with a control condition where patients simply read text in the mobile app instead. The study uses a randomised controlled design and patients are recruited from two different UK sites. Participants will receive either 6 or 12 sessions of STOP and we will measure clinical symptoms immediately and at 3 and 6 months later. These treatment data will be compared with data from similar people who take part in a control condition (reading text in the app) and are assessed at the same times. The data will show us whether there are any beneficial effects of STOP and, if so, how long they last. We will also measure in more detail exactly how many sessions produce enough symptom reduction to be clinically useful.

Data description (abstract)

Paranoia - defined as distressing worries about harm from others- is a common experience that can significantly impair daily life. Despite the burden it causes, many people experiencing paranoia do not access mental health services. Digital interventions offer an important opportunity to expand access to evidence-based support. The STOP (Successful Treatment of Paranoia) app is a stand-alone smartphone intervention that uses cognitive bias modification techniques to help users consider alternative interpretations of ambiguous, real-life social situations.

This study reports on data collected as part of a three-arm, double-blind, randomised controlled trial (RCT) designed to evaluate the efficacy and safety of STOP. A total of 274 participants with self-reported paranoia were recruited across clinical and non-clinical populations and randomly assigned to a 6-week STOP intervention, a 12-week STOP intervention, or an active control condition involving text reading. Participants completed assessments at baseline, post-treatment, and 18- and 24-week follow-up. The primary outcome was paranoid ideation; secondary outcomes included other clinical symptoms, recovery, and interpretation bias as a potential mechanism of change.

The trial achieved an 85% follow-up rate for the primary outcome at 24 weeks, and 88% of participants adhered to the treatment as per protocol. Adverse event rates were similar across trial arms, and all serious adverse events were determined to be unrelated to the intervention. Findings indicated that the 12-week version of STOP led to greater reductions in paranoia symptoms compared to the active control, with more modest improvements seen in the 6-week arm.

These results support the feasibility, safety, and potential clinical utility of STOP as a scalable digital intervention for paranoia. Future iterations should focus on enhancing personalisation to increase therapeutic relevance and maximise clinical benefit.

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